Shiraishi T, Nio Y, Imai S, Tsubono M, Morimoto H, Tseng C C, Tobe T, Tanaka T, Kitamura O, Sakanashi S
1st Department of Surgery, Faculty of Medicine, Kyoto University.
Nihon Gan Chiryo Gakkai Shi. 1990 Apr 20;25(4):799-811.
A biological response modifier, OK-432 (Picibanil) administered by injection has been used for cancer immunotherapy. The present study was designed to determine the optimal dose and frequency of oral administration of OK-432. Ninety-one stomach cancer patients were randomly assigned into 7 groups and were administered a placebo or OK-432 at a dose of 5, 20 or 40 KE, once or 3 times a week before their operation (5 KE X 1/W, 20 KE X 1/W, 40 KE X 1/W, or X3/W). ++Missregistration excluded 3 patients and the data of 88 patients were analysed. There was no significant difference in the background status of the patients in each group. The NK activity of PBL was augmented by the administration of 40 KE X 1/W or 20 KE X 3/W and that of RNL was augmented by the administration of 5 KE X 3/W or 40 KE X 1/W, in conjunction with an increase in the number of % positive cells of leu 11a+ or leu 19+ analysed by flow cytometry. The killing activity of PBL, RNL, or MNL against allogeneic lined gastric cancer cells (KATO III) was not augmented by the oral administration of OK-432 for one week. The skin reactivity to Su-PS or PPD, serum levels of tumor markers, or serum levels of immunoglobulins did not help in determining the optimal dose or its frequency. These results suggest that 5 KE X 3/W may be the optimal regimen to augment the antitumor immunity of RNL.
一种生物反应调节剂，注射用OK-432（沙培林）已用于癌症免疫治疗。本研究旨在确定OK-432口服给药的最佳剂量和频率。91例胃癌患者被随机分为7组，在手术前给予安慰剂或剂量为5、20或40KE的OK-432，每周1次或3次（5KE×1/周、20KE×1/周、40KE×1/周或×3/周）。++登记错误排除3例患者，对88例患者的数据进行了分析。各组患者的背景状况无显著差异。口服40KE×1/周或20KE×3/周可增强外周血淋巴细胞（PBL）的自然杀伤（NK）活性，口服5KE×3/周或40KE×1/周可增强脾细胞（RNL）的NK活性，同时通过流式细胞术分析的亮氨酸11a +或亮氨酸19 +阳性细胞百分比增加。口服OK-432一周并未增强PBL、RNL或单核细胞（MNL）对异基因系胃癌细胞（KATO III）的杀伤活性。皮肤对Su-PS或PPD的反应性、肿瘤标志物的血清水平或免疫球蛋白的血清水平无助于确定最佳剂量或给药频率。这些结果表明，5KE×3/周可能是增强RNL抗肿瘤免疫力的最佳方案。
